Incoming Inspection Lead

Job Description

Job Description

Incoming Inspections Lead

Location: Raleigh, NC (Onsite)
Salary: $80,000–$110,000

Position Summary

The Incoming Inspections Lead provides technical leadership and oversight for incoming inspection activities involving raw materials, components, and packaging materials to ensure compliance with cGMP, regulatory, and internal quality standards. This role serves as the Subject Matter Expert (SME) for incoming quality operations, partnering with Quality, Manufacturing, Procurement, Warehouse, Regulatory Affairs, and suppliers to ensure material quality, inspection readiness, and continuous improvement.

Key Responsibilities

• Lead and manage the incoming inspection program, ensuring all incoming materials meet quality specifications and regulatory requirements prior to release.
• Serve as the SME during FDA, EMA, and other regulatory inspections, including audit preparation and response activities.
• Provide technical leadership, coaching, mentoring, and training for incoming inspection analysts and technicians.
• Review and approve incoming inspection documentation, specifications, test methods, and analytical results.
• Ensure sampling and testing activities are performed in accordance with SOPs, cGMP, USP, and applicable compendial requirements.
• Develop and maintain sampling plans, material specifications, acceptance criteria, and testing procedures.
• Lead investigations involving nonconforming materials, OOS/OOT results, supplier quality issues, root cause analysis, and CAPA implementation.
• Support supplier quality activities, including material qualification, supplier audits, and change notifications.
• Manage lifecycle activities for incoming material specifications, including change control, periodic review, and continuous improvement.
• Ensure laboratory equipment and systems remain qualified, calibrated, maintained, and audit-ready.
• Maintain compliance with cGMP, USP, internal quality standards, and ALCOA+ data integrity requirements.
• Partner with QA, Manufacturing, Procurement, Warehouse, Regulatory Affairs, and Supply Chain to support timely material release and uninterrupted production.
• Drive continuous improvement initiatives to improve inspection efficiency, compliance, and operational effectiveness.
• Support audit readiness and participate in internal and external inspections.
• Promote safe laboratory and warehouse practices while identifying and escalating quality or safety concerns.
• Perform additional duties as assigned.

Required Qualifications

• Bachelor's degree in Chemistry, Biology, or another scientific discipline with 5+ years of relevant experience, or an equivalent combination of education and experience.
• Strong background in incoming inspection, raw material testing, or Quality Control within a cGMP-regulated pharmaceutical or biotechnology environment.
• Working knowledge of cGMP regulations, USP requirements, material specifications, ANSI/ASQ or ISO sampling plans, and quality systems.
• Demonstrated experience leading investigations involving nonconforming materials, supplier quality issues, OOS/OOT events, and CAPA implementation.
• Strong leadership, critical thinking, problem-solving, and decision-making skills.
• Excellent written and verbal communication skills with the ability to collaborate across multiple departments and external suppliers.

Preferred Qualifications

• Experience with LIMS, ERP systems (SAP preferred), and ALCOA+ data integrity principles.
• Lean Six Sigma or continuous improvement experience, including risk-based sampling or process optimization.
• Previous lead or supervisory experience within Quality Control or Incoming Inspection.
• Experience supporting supplier audits, supplier performance management, and external quality partnerships.

Work Environment

• Onsite position located in Raleigh, NC.
• Laboratory and warehouse environment within a pharmaceutical manufacturing facility.
• PPE required in designated areas.
• Ability to stand, walk, and perform inspection activities for extended periods.
• Ability to lift up to 50–75 pounds as needed.
• Flexibility to support operational needs, including occasional extended hours or schedule adjustments.

Key Competencies

• Strong analytical and critical thinking abilities.
• High attention to detail and data accuracy.
• Ability to interpret material specifications, Certificates of Analysis (CoAs), and technical documentation.
• Excellent organizational and prioritization skills.
• Proven leadership and mentoring capabilities.
• Strong interpersonal and cross-functional communication skills.
• Ability to make sound, quality-focused decisions in a fast-paced cGMP environment.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.